Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05291000 |
| Other study ID # |
83116987-662 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a randomized controlled study. The study was completed to with randomized
selected 30 training and reminder by watch (experiment), 30 education (experiment) and 30
control group total of 90 hypertensive patients. Patients in the experimental group received
training on hypertension and treatment adherence. In addition, the participants in the
training and reminder by watch group wore a medication reminder wristwatch. Statistically
significant differences were found in the post-test between scale scores of the experimental
and control groups (p<.05). It was observed that the initial blood pressure measurements were
high in the patients in all three groups, while the highest decrease was found in the
training and reminder by wristwatch group at the final measurement (p<.05). Hypertension
education program and using a medication reminder wristwatch were found to be effective in
increasing treatment adherence.
Description:
Design and Participants This study was conducted a randomized controlled trial. The
population of the research was the patients who received service from this center, who were
65 years of age and older, who had hypertension, and who were using at least one
antihypertensive drug (n=90). Power analysis was conducted to determine the sample size; it
was based on the difference in Compliance with Drug Therapy Scale mean scores of hypertensive
patients from previous studies.16 The sample size of at least 60 individuals was calculated
by taking α = 0.05, power = 0.99, and effect size = 0.863. Keeping in mind that the number of
participants may decrease during the study owing to factors such as a health problems or die
, 90 subjects were included in the study.
Participants were randomized to medication reminder wristwatch group (n = 30), training group
(n = 30) and control (n = 30) groups. In randomization, participants were stratified
participants was ensured through the use of stratified sampling method. The patients in all
three groups were stratified according to gender (female, male). The patients who were 65 and
older, who were diagnosed with hypertension, who used at least one antihypertensive drug, who
are literate and open to communication and cooperation, who had blood pressure of 140/90mmHg
or above prior to the research, who had a score of 8 and above from the Compliance with Drug
Therapy Scale, and who were willing to participate were included in the study. The patients
who met the inclusion criteria constituted the sample of the study.
A questionnaire form, Hypertension Information Form (HIF), Antihypertensive Medication
Treatment Adherence Scale (AMTAS), Medication Adherence Self-Efficacy Scale Short Form
(MASES-SF) were used to collect data. The questionnaire form was developed by using relevant
literature and included 33 closed-ended questions about the sociodemographic, health/disease
and treatment compliance characteristics of elderly individuals.
Hypertension Information Form (HIF) was prepared by the researcher in line with the
literature in order to measure the effectiveness of the hypertension education program. It
contains 26 statements about drug use, blood pressure monitoring, and disease management. The
questions are Yes/No questions. The "yes" answers receive 1 point, while the "no" answers
receive 0 point. The maximum score that can be obtained from the form is 26. A score of 13
and above indicates that patients' knowledge level about hypertension has increased. The
current study found Cronbach α = 0.77.
AMTAS is a questionnaire developed by Morisky et al to evaluate medication adherence of
individuals with hypertensive in 2003. The scale includes 9 statements to diagnose the
medication behavior and the total score varies between 1 and 13. Individuals with a score
between 1 and 7 are defined as compliant with treatment, while individuals with a score of 8
and above are defined as non-compliant with treatment. The Turkish version of the AMTAS was
validated by Demirezen et al with Cronbach α = 0.82. In this study, the Cronbach's alpha of
the scale was determined as 0.51.
MASES-SF was developed in 2012 by Hacıhasanoğlu et al and include of 13 questions on a Likert
scale. The total score of the scale is between 13 and 52, and an increase in the score
indicates that the individual's level of compliance with antihypertensive drug treatment is
good. The Cronbach's alpha was reported as 0.94. In this study, the Cronbach's alpha of the
scale was found to be 0.83.
The study was conducted between April 2019 and November 2020. In the first meeting, The
questionnaire form, HIF, AMTAS, MASES-SF were administered. Data were collected using the
face-to-face interview method.
Ethical approval was obtained from the ethical board (February 18, 2018, No. 83116987-662)
and permission was given from the Provincial Health Directorate (February 28, 2019, No.
87064461-044). Participants were informed about the scope of the study and verbal and written
informed consent was obtained. Educational material was given to participants of the control
group after the last home visit.
The data were analyzed using the SPSS 23.0. Chi-square and Fisher's Exact Tests were used to
compare the categorical variables across the groups. One-way Analysis of Variance was used to
compare the data that show normal distribution according to groups of three or more, and the
Kruskal Wallis Test was used to compare data that were not normally distributed. The paired
two-sample t-test was used to compare normally distributed data according to paired time, and
the Wilcoxon Test was used to compare the data that did not show normal distribution. The
McNemar Test was used to compare the categorical variables according to pretest and posttest.
For statistical significance, P < .05 was used.
